Evaluating the Feasibility of VR for Pediatric Renal Biopsies

NCT05267704 | Completed Results FDA Device

• 1 other identifier: 21-35095
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the use of virtual reality (VR) as an adjunct or alternative to pharmacologic sedation in pediatric patients undergoing renal biopsy.

Conditions

Pain, Procedural; Procedural Anxiety; Sedation Complication

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures

  Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (Likert scale, with 1 = "strongly disagree" as most dissatisfied with VR experience and 5 = "strongly agree" as most satisfied with VR experience and a better perceived outcome

  From arrival to procedural room to completion of procedure (~30 minutes)

• Number of Parents Who "Agreed" or "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures

  Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (Likert scale, with 1 = "strongly disagree" as most dissatisfied with VR experience and 5 = "strongly agree" as most satisfied with VR experience and a better perceived outcome

  From arrival to procedural room to completion of procedure (~30 minutes)

Secondary Outcomes (2)

• Mean Difference in Self-reported Procedural Anxiety (Change in Childhood Anxiety Meter)

  From arrival to procedural room to completion of procedure (~30 minutes)

• Mean Difference in Self-reported Procedural Anxiety (Change in Child Fear Scale)

  From arrival to procedural room to completion of procedure (~30 minutes)

Study Arms (1)

VR Arm

EXPERIMENTAL

Pediatric patients age 5-17 using the VR headset during renal biopsy.

Device: Oculus Go Virtual Reality Headset

Interventions

Oculus Go Virtual Reality Headset DEVICE

VR headset displaying preselected game during renal biopsy

VR Arm

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Patients age 5-17 receiving a renal biopsy at the University of California, San Francisco (UCSF) Benioff Children's Hospital

You may not qualify if:

• Patients who cannot lie supine for their renal biopsy will be excluded from the study
• Patients with injuries to the head/face that would prohibit wearing a headset
• Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
• Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
• Patients with a history of or current symptoms of vertigo
• Patients who are blind
• Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
• Patients on whom the VR headset does not fit appropriately

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Benioff Children's Hospital

San Francisco, California, 94143, United States

Location

Related Publications (3)

• Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.

  PMID: 32618627 BACKGROUND

• Taylor JS, Chandler JM, Menendez M, Diyaolu M, Austin JR, Gibson ML, Portelli KI, Caruso TJ, Rodriguez S, Chao SD. Small surgeries, big smiles: using virtual reality to reduce the need for sedation or general anesthesia during minor surgical procedures. Pediatr Surg Int. 2021 Oct;37(10):1437-1445. doi: 10.1007/s00383-021-04955-6. Epub 2021 Jul 16.

  PMID: 34269867 BACKGROUND

• Goldman RD, Behboudi A. Virtual reality for intravenous placement in the emergency department-a randomized controlled trial. Eur J Pediatr. 2021 Mar;180(3):725-731. doi: 10.1007/s00431-020-03771-9. Epub 2020 Aug 10.

  PMID: 32779029 BACKGROUND

Related Links

• Samsung Gear VR Headset

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations include selection bias for those who want to participate in VR experience and also the team's inability to blind participants/providers. In addition, the selection of an appropriate VR environment is challenging for various procedures and age groups.

Results Point of Contact

• Title: Omar Salman, MD
• Organization: University of California, San Francisco

omar.salman@childrens.harvard.edu

6159733909

Study Officials

• Justin Libaw, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: March 4, 2022
• Study Start: October 11, 2022
• Primary Completion: September 8, 2024
• Study Completion: September 10, 2024
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)